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The effect of bupivacaine liposomes on sleep quality and postoperative cognitive impairment in patients with hip fractures

The effect of bupivacaine liposomes on sleep quality and postoperative cognitive impairment in patients with hip fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110288
Enrollment
Unknown
Registered
2025-10-11
Start date
2025-10-11
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip fracture refers to a fracture of the femoral neck, femoral trochanter, or upper one-third of the femoral shaft (more than 5cm below the lesser trochanter)

Interventions

Control group:5ml bupivacaine injection (25mg) + 25ml normal saline (total 30ml)
Experimental Group:20ml of liposomal bupivacaine (266mg) +5ml of bupivacaine injection (50mg) +5ml of normal saline (total 30ml)

Sponsors

Wuxi people’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Hip fracture patients undergoing surgical treatment under general anesthesia (including femoral neck fractures, intertrochanteric fractures; 2.The patient's ASA grade is ?-?; 3.Voluntary signing of informed consent form;

Exclusion criteria

Exclusion criteria: 1.Complex trauma: Patients with multiple fractures, including trauma to non-hip sites (e.g., head, chest, pelvis, and extremities); 2.History of mental illness or current use of psychotropic medications; 3.Preoperative delirium or consideration of using delirium treatment medications (e.g., olanzapine, haloperidol); 4.History of acute cerebrovascular disease (intracerebral or subarachnoid hemorrhage within 6 months); 5.Patients with impaired communication or language disorders; 6.Patients requiring sedation due to their condition or expected to be comatose postoperatively; 7.Allergy to amide-type local anesthetics; 8.Polycystic ovary syndrome or Wolff-Parkinson-White syndrome; 9.Second-degree or third-degree atrioventricular block/sinoatrial node syndrome without a pacemaker; 10.Admission electrocardiogram showing a ventricular rate <50 beats/min or Q-T interval prolongation; 11.Severe hepatic or renal insufficiency; 12.Participation in other clinical studies; 13.History of drug addiction or abuse; 14.Significant coagulation dysfunction or requirement for blood transfusion;

Design outcomes

Primary

MeasureTime frame
Sleep quality;Mental status;

Secondary

MeasureTime frame
Related inflammatory factors (IL - 1ß, IL - 6, TNF - a);Postoperative adverse reactions (dizziness, nausea and vomiting, hypotension, respiratory depression, bradycardia) and their frequencies;Length of hospital stay;Pain scores at rest and during movement and area under the curve (AUC);Dosages of sufentanil and flurbiprofen axetil after surgery;

Countries

China

Contacts

Public ContactLu Shunmei

Wuxi People's Hospital

lushunmei2008@163.com+86 510 8535 0835

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026